VANGUARD COMPLETE KNEE SYSTEM 195924Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
All models of Vanguard Complete Knee System (27)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304560482), received between Feb 18, 2020 and Feb 18, 2020 — classified as 1 injury.
1 other recall cover devices cleared under the same FDA submission (K141407); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Adhesion(s)1
- Limited Mobility Of The Implanted Joint1
- Scar Tissue1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Adhesion(s); Limited Mobility Of The Implanted Joint; Scar Tissue
MAUDE report 9722438 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K141407. One submission often covers many models, so check the product and lot details in each record.
- Z-1265-2016 · Feb 5, 2016 · TerminatedVanguard XP Knee System Porous Femoral Component various sizes and orientation a total knee replacement system. prosthesis, knee, patella/femorotibial, semi-constrained, uncement
Other Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer devices
- Regenerex 141356Biomet Orthopedics, LLC · Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer1 recall5 reports
- BIOMET KNEE SYSTEM 141215Biomet Orthopedics, LLC · Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer1 recall3 reports
- Regenerex 141358Biomet Orthopedics, LLC · Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer1 recall1 report
- Vanguard Knee System 189720Biomet Orthopedics, LLC · Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer1 recall0 reports
- Vanguard Knee System 189704Biomet Orthopedics, LLC · Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer1 recall0 reports
- Vanguard Knee System 189320Biomet Orthopedics, LLC · Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer1 recall0 reports
- Vanguard Knee System EP-183608Biomet Orthopedics, LLC · Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer1 recall0 reports
- Biomet® 360 Knee System 185204Biomet Orthopedics, LLC · Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer5 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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